EUCTR2019-004878-26-DE进行中（未招募）1 期
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Efficacy, and Biomarker Response of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Confirmed diagnosis of UC at least 3 months’ duration prior to screening
- •- Moderately to severely active UC as assessed by the modified Mayo score
- •- Documentation of an inadequate response, loss of response, or intolerance to a treatment course of 1 or more of the following standard of care medications: oral 5-aminosalicylic acids, corticosteroids, immunomodulators, anti-tumor necrosis factor (TNF) agents, integrin inhibitors
- •- Documentation of prior treatment with corticosteroids for = 4 weeks
- •- Males and females must agree to follow specific methods of contraception, if applicable
- •Other protocol-defined inclusion criteria apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 93
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 7
排除标准
- •- Current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC), ischemic colitis, pseudomembranous colitis
- •- Current evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
- •- History or evidence of any extensive colonic resection, or subtotal or total colectomy
- •- Women who are pregnant or breastfeeding
- •- Prior exposure to BMS-986165 or a TYK2 inhibitor
- •Other protocol-defined exclusion criteria apply.
研究者
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